CEPA: LESSONS FOR CHEMICAL REGULATION Joseph F. Castrilli, Counsel - - PowerPoint PPT Presentation

CEPA: LESSONS FOR CHEMICAL REGULATION

Joseph F. Castrilli, Counsel Canadian Environmental Law Assoc. Webinar: Science Meets Law December 12, 2019

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Overview

What is CELA? Nature of the Problem Posed by Toxic Substances in Canada CEPA

Existing Chemicals New Substances

Looking Forward

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What is CELA?

• Non-profit organization established in 1970 to

use existing laws to protect the environment and to advocate environmental law reforms

• Funded by Legal Aid Ontario - Provides free

legal advice to the public & legal representation at hearings and in courts on behalf of those

• therwise unable to afford legal assistance
• Also undertakes education & research projects

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Nature of the Problem

• Approx. 23,000 chemicals in use in Canada DSL
• Approx. 58,000 chemicals on NDSL
• Some cause cancer, birth defects, endocrine

disruption, neurological & behavioural impacts…

• Ontario: #2 in North America for release of

developmental/reproductive toxicants (CEC 2004)

• Ontario: #4 in North America for release of

known/suspected carcinogens (CEC 2004)

• Ontario: responsible for 36% of air / 50% of

water discharges in Canada (Ontario 2008 Discussion Paper on Toxics Reduction Law)

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Timeline History of CEPA

• Canada has had toxic substance

legislation in one form or another since the mid-1970s

• Environmental Contaminants Act (1975 –

1988)

• Canadian Environmental Protection Act

(1988 – 1999)

• CEPA,1999 (current law)

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CEPA: Introduction

• Canadian Environmental Protection Act,1999 –

principal law governing manufacture, import, & use of chemicals in Canada

• Primary purpose “to contribute to sustainable

development through pollution prevention” (CEPA,1999 – Declaration); also

• “Virtually eliminate most persistent &

bioaccumulative toxic substances” (Preamble)

• Federal government duties include: protection of

environment & human health through application

• f precautionary principle (s. 2)

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CEPA: What is toxic?

• Under CEPA,1999 a substance must be

declared “toxic” before Canada can act to reduce exposure

• “toxic” defined as a substance entering or

that may enter the environment in a quantity or concentration or under conditions that:

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CEPA: What is toxic?

• Have or may have immediate / long-term

effect on environment or its biological diversity;

• Constitute or may constitute danger to

environment on which life depends; or

• Constitute or may constitute danger in

Canada to human life or health (s. 64)

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CEPA: What is toxic?

• If a substance meets s. 64 test it can be

added to Schedule 1 of Act (List of Toxic Substances) & become eligible for regulation (following public notice, comment and Board of Review hearings)

• For both existing and new chemicals

CEPA,1999 applies risk assessment approach to determine whether s. 64 test met

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CEPA: Existing Chemicals

• If a substance is on the Domestic

Substances List it is deemed an existing substance; & would be on that list if it was used, manufactured, imported for commercial purposes in volumes greater than 100 kg between January 1, 1984 & December 31, 1986 (s. 66, CEPA,1999)

• Approximately 23,000 substances on DSL

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CEPA: Existing Chemicals

• Substances on DSL categorized as to

persistence, bioaccumulative, toxic, & exposure potential to humans & environment within 7 years after CEPA,1999 became law (s. 73)

• Substances not on DSL placed in non-DSL list &

cannot be manufactured or imported unless information first provided to government of Canada (essentially deemed to be new substances)

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CEPA: Existing Chemicals

• Assessment of DSL substances to

determine which should be deemed toxic & placed in Schedule 1 has been on-going under CEPA,1999 & predecessor law

• To expedite review of existing substances

categorization process authorized under s. 73 to identify chemicals that should be subjected to screening level risk assessment (s. 74)

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CEPA: Existing Chemicals

• Under categorization, chemicals were

assessed on:

– Environmental criteria (3): persistence (P); bioaccumulation (B) and; inherent toxicity (iTe) to aquatic organisms; & – Health criteria (2): greatest potential for exposure (GPE); and inherent toxicity to humans (iTh) – Canada completed categorization process by September 2006

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What is Categorization?

Source: Environment Canada, Categorization of the Domestic Substances List For Persistence, Bioaccumulation, and Inherent Toxicity to Ecological Organisms, Technical Briefing to NGOs, April 20, 2006

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Categorization Results

• Categorization of 23,000 DSL chemicals

resulted in Canada finding that 4,300 required further evaluation organized into 3 groups:

• High priority – PBiTs, GPE/IPE and high hazard

to humans

• Medium priority – P/BiT, GPE/IPE and medium

hazard

• Low priority – P/BiT to aquatic environment,

mainly low volume

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Categorization Results - 4300

Substances

Source: Government of Canada, Presentation to the CMP Stakeholder Advisory Council, January 30 2009, Ottawa

4300 Priorities 2600 Med Priorities 500 High Priorities 1200 Low Priorities

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CEPA: Existing Chemicals - CMP

• In December 2006, Canada announced

new approach known as the Chemicals Management Plan, to address results of categorization by 2020

• Major focus of CMP: collect additional

information on 4,300 substances out of 23,000 that require further assessment to determine if toxic to human health/environ.

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CEPA: Existing Chemicals – Risk Management

• CEPA-toxic chemicals go on Schedule 1
• f Act & are eligible for risk management
• Risk management options include:

– Regulation (ban, restrict use or release, etc) – Pollution prevention (requiring minimization / avoidance of waste creation, etc) – Significant new activity (SNAC) (notification by industry beyond current uses) – Voluntary env. performance agreement

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CEPA: Existing Chemicals – CMP Summary

• CMP Focus:

– Data collection – updates to inventories (DSL & NPRI) – Risk assessment – screening level risk assessments – Risk management measures for industrial & consumer applications of substances considered CEPA-toxic

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Risk Assessment / Management Process

EC HC Draft Environmental Assessment

s.64 (a) & (b)

Gazette Notice Proposed conclusion “Toxic or non-toxic”

s.77(1) Maximum 18 months Maximum 24 months

Assessment Management

Self-imposed Timelines for Challenge Draft Human Health Assessment

s.64 (c)

Gazette Notice Ministers Final conclusion “Toxic or non-toxic”

s.77(6)

Gazette Notice Proposed Order “Addition to List of Toxic Substances” (Schedule 1

• f CEPA)

s.77(9) & 90(1)

Gazette Notice Final Order “Addition to List of Toxic Substances” (Schedule 1

• f CEPA)

s.77(9) & 90(1)

Gazette Notice Proposed RM Instrument

• s. 91(1)

60-day public comment period 60-day public comment period 60-day public comment period Public consultation on proposed conclusion Ministerial decision-making Governor-in-council decision-making Ministerial or Governor-in-council decision-making Gazette Notice Final RM Instrument

• s. 91(1)

Source: Environment Canada, An Overview of the Chemicals Management Plan and Challenge, presentation to the CMP Stakeholder Advisory Council, January 25, 2008.

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CEPA: Existing Chemicals – Categorization / CMP Gaps

• Gap # 1- A chemical considered P & B

does not meet categorization environment criteria & is not considered for further screening or reduction action

– Must also be inherently toxic – Over 250 DSL substances P & B but not iTe – Therefore, not assessed or managed under CMP

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CEPA: Existing Chemicals – Categorization / CMP Gaps

• Gap # 2 – Many substances not meet very

high CMP PBT criteria (e.g. P if ½ life in water =/> 26 weeks); if CMP applied criteria from other jurisdictions, more chemicals would be PBT under CEPA

– GLWQA (Can-US) (P if ½ life water 8 weeks) – REACH (Europe) (5.7 weeks) – PBT (USEPA) (8.5 weeks) – Stockholm POPs Convention (8.5 weeks)

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CEPA: Existing Chemicals – Categorization / CMP Gaps

• Gap # 3 – Categorization health effects

assessments considered carcinogenicity, genotoxicity, reproductive toxicity, developmental toxicity, and mutagenicity, but did not consider endocrine toxicity

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CEPA: Existing Chemicals – Categorization / CMP Gaps

• Gap # 4 – DSL list over 30 years old and

subject to inaccuracies

– 2001 Health Canada study found quantities of 7 of 110 chemicals surveyed were order of magnitude greater than 1986 base year – NPRI data can update release information for chemicals on both lists but NPRI only reports

• n roughly 350 chemicals from large facilities

– Can lead to wrong conclusions about exposure and incorrect management action

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CEPA: Existing Chemicals – Categorization / CMP Gaps

• Gap # 5 – Uncertainty regarding

categorization results due to data gaps

– Categorization relied on existing data – Missing information & data gaps filled by use

• f models (QSAR) & analogues (information

from a similar but not identical chemical) – Categorization made limited use of surveys to gather data from industry; did not consider breakdown products of parent chemicals or toxicity for parent chemicals’ full life cycle

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CEPA: Existing Chemicals – Categorization / CMP Gaps

• Gap # 6 – No further risk assessment work
• r risk management action planned for

25% of chemicals (754) categorized as low priority due to low use (less than 1000 kg per year) but which were identified as PiTe & BiTe

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CEPA: Existing Chemicals – Categorization / CMP Gaps

• Gap # 7 – Canada does not propose any

further action on chemicals under CMP already found to be CEPA-toxic & placed in Schedule 1 under earlier processes

– Already considered managed under CEPA though some still pose problems (e.g. lead, cadmium, arsenic, particulate matter, benzene, & nonylphenol ethoxylates)

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CEPA: Existing Chemicals – Categorization / CMP Gaps

• Gap # 8 – Risk management options do

not focus on phase out, elimination, or use

• f safer alternatives

– For 7 chemicals found to be carcinogenic & CEPA-toxic in Batch 1 of Industry Challenge, risk management options focused on release monitoring and SNAC

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CEPA: Existing Chemicals – Categorization / CMP Gaps

• Gap # 9 – Little correspondence between

categorization results and mandatory reporting requirements under NPRI

– NPRI is CEPA’s main inventory for annual tracking of releases & transfer of chemicals – But all chemicals identified through categorization not listed for NPRI reporting – Canada has yet to resolve issue

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CEPA: New Chemicals

• A chemical is “new” if not listed on DSL as

having been in Canadian commerce between January 1, 1984 & December 31, 1986

• Two means by which new chemicals enter

Canadian market:

– New Substance Notification Regulations (NSNR); & – Non-DSL

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CEPA: New Chemicals - NSNR

• Government assesses new substance

following notice by company of intention to manufacture or import to Canada (PMN)

• Company must submit different types of

data depending on volume of proposed new substance to be manufactured or imported (# of NSNR Schedules)

• Substances assessed on basis of risk –

not automatically prohibited even if PBT

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CEPA: New Chemicals - NSNR

• If proposing to import or manufacture 100

to 1000 kg per year of a substance new to Canada, information required includes:

– MSDS – Intended use – Human health environmental hazard information in possession – No toxicity information explicitly required – Short government assessment period after which may enter Canadian commerce

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CEPA: New Chemicals - NSNR

• If proposing to import or manufacture 1000

to 10000 kg per year of a substance new to Canada, information required includes:

– Physical / chemical data – Acute toxicity / mutagenicity testing – Exposure information – Whether chemical will be used in products for children – 60 day assessment period unless otherwise notified

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CEPA: New Chemicals - NSNR

• If proposing to import or manufacture more

than10000 kg per year of a substance new to Canada, information required includes:

– Skin irritation / skin sensitization testing – Repeated dose toxicity – Additional mutagenicity test data – Minimum 75-day assessment applies during which Canada may ask for more information

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CEPA: New Chemicals – NDSL

• NDSL = substances in use internationally but not on

DSL; are subject to NSNR requirements but benefit from reduced information requirements under NSNR than would be required for a “brand new” substance introduced to Canada

• NDSL primarily based on US TSCA inventory
• NDSL substances assigned less onerous data &

assessment time frame requirements under NSNR (e.g. only need meet 1000 kg reqs where 10000 kg reqs otherwise apply) but also submit USEPA assessment & management information

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CEPA: New Chemicals – Gaps

• Gap # 1 – Inadequate data required for

new substances

– NSNR regulations & schedules silent on need for carcinogenicity, neurodevelopmental toxicity, & endocrine disruption data even for highest volumes of new chemicals being introduced (though Canada does have authority to request such information) – With some exceptions, NSNR regulations & schedules silent on need for P & B data

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CEPA: New Chemicals – Gaps

• Gap # 1 – Inadequate data - continued

– NDSL reliance on reduced NSNR requirements because such substances on TSCA inventory may be a problem – 85% of new chemicals introduced in US have no health test data (“Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess Health Risks and Manage Its Chemical Review Program” GAO 2005, page 11)

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CEPA: New Chemicals – Gaps

• Gap # 1 – Inadequate data – continued

– “TSCA does not require chemical companies to test new chemicals for toxicity & to gauge exposure levels before they are submitted for review and, according to EPA officials, chemical companies typically do not voluntarily perform such testing” (GAO 2005, page 10)

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CEPA: New Chemicals – Gaps

• Gap # 1 – Inadequate data – continued

– Hinders Canada’s ability to assess effectively new substances entering Canada by lowering the bar for chemicals already on US market – Chemicals at higher volumes of import or use that are on TSCA inventory & NDSL do not have to meet same criteria as other chemicals not on DSL – Allows chemicals to enter Canada with less data than otherwise required by NSNR

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CEPA: New Chemicals – Gaps

• Gap # 2 – Lack of public participation &

transparency on new substances

– For existing chemicals, assessments are made public & include public comment period – But no notice & comment occurs for new chemicals unless Canada determines chemical is toxic & imposes use conditions or SNAC requirements

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Looking Forward: Recommendations

• Improvements to CEPA necessary for:

– Risk assessments (RA) – Risk management strategies (RMS)

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Looking Forward: Recommendations

• RA improvements (to Act, regulations):

– Address data gaps – Consider potential for harm at lower exposure – Focus more on vulnerable populations – Address cumulative / synergistic effects – Consider more health endpoints (e.g. endocrine disruption) – Focus more on environmental fate & long- range transport

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Looking Forward: Recommendations

• RMS improvements (to Act, regulations):

– Enhance pollution prevention authority – Authorize substitution planning (i.e. to identify / use safer alternatives) – Enhance monitoring authority – Improve public transparency & reporting – Better application of precautionary principle where data absent

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Looking Forward: Recommendations

• 31 recommendations of House of

Commons Standing Committee on Environment & Sustainable Development (April 2007) – never acted on

• 24 recommendations of Senate Standing

Committee on Energy, Environment, & Natural Resources (March 2008) - ditto

• Arise from s. 343 CEPA: 5-year review

Looking Forward: Recommendations

• 87 recommendations of House of

Commons Standing Committee (June 2017) – not acted on to date

• Arise from 2016 review under s. 343

CEPA

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NGO Draft Amendments

• Oct 2018, 30 organizations presented

ECCC with 50 pages of proposed amendments to CEPA

• Addressed control of EDS; protection of

vulnerable populations; substitution of safer alternatives

• Will there be uptake by Parliament?

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NGO Draft Amendments

• Part 3 – amend CEPA to grant any person

right to petition Minister to add substance to NPRI if substance may harm a vulnerable population, or substance is of very high concern, and require Minister to respond within specified time

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NGO Draft Amendments

• Part 4 – amend CEPA to require person

preparing pollution prevention plan to specify how precautionary, substitution, polluter pays, and environmental justice principles have been incorporated into plan, and require Minister to issue notice to person to send plan to Minister for review if plan more than 5 years old

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NGO Draft Amendments

• Part 5 – amend CEPA to apply

categorization and screening level assessments to EDS in their own right

• Remove no further action option from

Minister where substance found to be toxic

• Must consider vulnerable populations,

aggregate/cumulative effects, & safer alternatives as part of prevention/control

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NGO Draft Amendments

• Part 5 – amend CEPA to add re-

evaluation/ special review measures for substances previously subjected to categorization/screening

• burden of persuading Ministers that risks

acceptable rests with manufacturer, importer, user during categorization, screening, re-evaluation, special review

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NGO Draft Amendments

• Part 5 – where substance not added to

Schedule 1 List of Toxic Substances following a finding of toxicity during screening, re-evaluation, or special review, after 2 years any person may apply to Federal Court requiring this be done

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NGO Draft Amendments

• New part 5.1 – all schedule 1 substances

are identified as “priority toxic substances” and are made subject to safer alternatives regime set out in the new Part 5.1

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Looking Forward: Conclusions

• Are Ontario toxic substance emission levels

advertisement for CEPA as law reform model?

• High emissions in Ontario may be function of

adequacy of Ontario law, but query whether CEPA part of problem

• Gaps in CEPA regarding existing & new

chemicals suggest room for improvement that would aid Ontario, rest of Canada, & serve as true law reform model within & beyond national borders in protecting health & environment

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Contact Information

Joseph F. Castrilli, Counsel Canadian Environmental Law Association 55 University Ave., Ste. 1500 Toronto, Ontario, M5J 2H7 Tel: 416-960-2284, ext.7218 Fax: 416-960-9392 Email: castrillij@sympatico.ca

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Additional Information

CELA www.cela.ca Canada’s Chemicals Management Plan (Government of Canada) http://www.chemicalsubstanceschimiques.gc.c/ Parliament of Canada www.parl.gc.ca